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BACKGROUND: Anastomotic leakage is a severe postoperative complication in colorectal surgery and compromised bowel perfusion is considered a major contributing factor. Conventional methods to assess bowel perfusion have a low predictive value for anastomotic leakage. We therefore aimed to evaluate the efficacy of real-time assessment with near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) in the prevention of anastomotic leakage. METHODS: This multicentre, randomised, controlled, phase 3 trial was done in eight hospitals in the Netherlands. We included adults (aged >18 years) who were scheduled for laparoscopic or robotic colorectal surgery (with planned primary anastomosis) for benign and malignant diseases. Preoperatively, patients were randomly assigned (1:1) to fluorescence-guided bowel anastomosis (FGBA) or conventional bowel anastomosis (CBA) by variable block randomisation (block sizes 4, 6, and 8) and stratified by site. The operating surgeon and investigators analysing the data were not masked to group assignment. Patients were unmasked after the surgical procedure or after study end. In the FGBA group, surgeons marked anastomosis levels per conventional perfusion assessment and then administered 5 mg of ICG by 2 mL intravenous bolus. They assessed bowel perfusion using NIR fluorescence imaging and adjusted (or kept) transection lines accordingly. Only conventional methods for bowel perfusion assessment were used in the CBA group. The primary outcome was the difference in the rate of clinically relevant anastomotic leakage (ie, requiring active therapeutic intervention but manageable without reoperation [grade B] or requiring reoperation [grade C], per the International Study Group of Rectal Cancer) between the FGBA group and the CBA group within 90 days post-surgery. The primary outcome and safety were assessed in the intention-to-treat population. This study was registered with ToetsingOnline.nl (NL7502) and ClinicalTrials.gov (NCT04712032) and is complete. FINDINGS: Between July 2, 2020, and Feb 21, 2023, 982 patients were enrolled, of whom 490 were assigned to FGBA and 492 were assigned to CBA. After excluding 51 patients, the intention-to-treat population comprised 931 (463 assigned FGBA and 468 assigned CBA). Patients had a median age of 68·0 years (IQR 59·0-75·0) and 485 (52%) were male and 446 (48%) were female. Ethnicity data were not available. The overall 90-day rate of clinically relevant anastomotic leakage was not significantly different between the FGBA group (32 [7%] of 463 patients) and the CBA group (42 [9%] of 468 patients; relative risk 0·77 [95% CI 0·50-1·20]; p=0·24). No adverse events related to ICG use were observed. 313 serious adverse events in 229 (25%) patients were at 90-day follow-up (159 serious adverse events in 113 [24%] patients in the FGBA group and 154 serious adverse events in 116 [25%] patients in the CBA group). 18 (2%) people died by 90 days (ten in the FGBA group and eight in the CBA group). INTERPRETATION: ICG NIR fluorescence imaging did not reduce 90-day anastomotic leakage rates in this trial across all types of colorectal surgeries. Further research should be done in subgroups, such as rectosigmoid resections, for which evidence suggests ICG NIR might be beneficial. FUNDING: Olympus Medical, Diagnostic Green, and Intuitive Foundation.
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OBJECTIVE: In this pilot study, we investigated the feasibility of response prediction using digital [ 18 F]FDG PET/computed tomography (CT) and multiparametric MRI before, during, and after neoadjuvant chemoradiation therapy in locally advanced rectal cancer (LARC) patients and aimed to select the most promising imaging modalities and timepoints for further investigation in a larger trial. METHODS: Rectal cancer patients scheduled to undergo neoadjuvant chemoradiation therapy were prospectively included in this trial, and underwent multiparametric MRI and [ 18 F]FDG PET/CT before, 2â weeks into, and 6-8â weeks after chemoradiation therapy. Two groups were created based on pathological tumor regression grade, that is, good responders (TRG1-2) and poor responders (TRG3-5). Using binary logistic regression analysis with a cutoff value of P â ≤â 0.2, promising predictive features for response were selected. RESULTS: Nineteen patients were included. Of these, 5 were good responders, and 14 were poor responders. Patient characteristics of these groups were similar at baseline. Fifty-seven features were extracted, of which 13 were found to be promising predictors of response. Baseline [T2: volume, diffusion-weighted imaging (DWI): apparent diffusion coefficient (ADC) mean, DWI: difference entropy], early response (T2: volume change, DWI: ADC mean change) and end-of-treatment presurgical evaluation MRI (T2: gray level nonuniformity, DWI: inverse difference normalized, DWI: gray level nonuniformity normalized), as well as baseline (metabolic tumor volume, total lesion glycolysis) and early response PET/CT (Δ maximum standardized uptake value, Δ peak standardized uptake value corrected for lean body mass), were promising features. CONCLUSION: Both multiparametric MRI and [ 18 F]FDG PET/CT contain promising imaging features to predict response to neoadjuvant chemoradiotherapy in LARC patients. A future larger trial should investigate baseline, early response, and end-of-treatment presurgical evaluation MRI and baseline and early response PET/CT.
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Imágenes de Resonancia Magnética Multiparamétrica , Neoplasias del Recto , Humanos , Fluorodesoxiglucosa F18 , Tomografía Computarizada por Tomografía de Emisión de Positrones , Terapia Neoadyuvante , Proyectos Piloto , Tomografía Computarizada por Rayos X , Neoplasias del Recto/diagnóstico por imagen , Neoplasias del Recto/terapia , Neoplasias del Recto/patología , Quimioradioterapia , Resultado del Tratamiento , RadiofármacosRESUMEN
Current imaging modalities frequently misjudge disease stage in colorectal, gastric and pancreatic cancer. As treatment decisions are dependent on disease stage, incorrect staging has serious consequences. Previous preclinical research and case reports indicate that prostate-specific membrane antigen (PSMA)-targeted PET/CT imaging might provide a solution to some of these challenges. This prospective clinical study aims to assess the feasibility of [18F]DCFPyL PET/CT imaging to target and visualize primary colon, gastric and pancreatic cancer. In this prospective clinical trial, patients with colon, gastric and pancreatic cancer were included and underwent both [18F]DCFPyL and [18F]FDG PET/CT scans prior to surgical resection or (for gastric cancer) neoadjuvant therapy. Semiquantitative analysis of immunohistochemical PSMA staining was performed on the surgical resection specimens, and the results were correlated to imaging parameters. The results of this study demonstrate detection of the primary tumor by [18F]DCFPyL PET/CT in 7 out of 10 patients with colon, gastric and pancreatic cancer, with a mean tumor-to-blood pool ratio (TBR) of 3.3 and mean SUVmax of 3.6. However, due to the high surrounding uptake, visual distinction of these tumors was difficult, and the SUVmax and TBR on [18F]FDG PET/CT were significantly higher than on [18F]DCFPyL PET/CT. In addition, no correlation between PSMA expression in the resection specimen and SUVmax on [18F]DCFPyL PET/CT was found. In conclusion, the detection of several gastrointestinal cancers using [18F]DCFPyL PET/CT is feasible. However, low tumor expression and high uptake physiologically in organs/background hamper the clear distinction of the tumor. As a result, [18F]FDG PET/CT was superior in detecting colon, gastric and pancreatic cancers.
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INTRODUCTION: Several factors are included in decision making for treatment of patients with locally advanced rectal cancer, including a trade-off between risks and gains of both clinical and functional outcomes. However, it is largely unknown which outcomes are most important to patients and whether this differs between patients and clinicians. METHODS: Both clinicians and patients treated for locally advanced rectal cancer were invited to fill out an online questionnaire, including a choice-based conjoint experiment. Participants were presented 14 comparisons of two hypothetical case presentations, characterized by different treatments and outcomes of care (6 attributes) and were asked to select the case with the best outcome at that moment. Hierarchical Bayes Estimation was used to calculate the relative importance (RI) of each of the six attributes. RESULTS: In total, 94 patients and 128 clinicians completed the questionnaire. For patients, avoiding surgery with permanent stoma was most important (RI 24.4, 95%CI 21.88-26.87) and a 2-year difference in disease-free survival was least important (RI 5.6, 95%CI 4.9-6.2). Clinicians assigned highest importance to avoiding severe and daily worries about cancer recurrence (RI 30.7, 95%CI 29.1-32.4), while this was ranked 4th by patients (RI 17.9, 95%CI 16.5-19.4, p < 0.001). CONCLUSION: When confronted with different outcomes within one case description, patients find the duration of disease free survival the least important. In addition, considerable differences were found between the importance assigned by patients and clinicians to clinical and functional outcomes, most notably in avoiding surgery with permanent stoma and worries about recurrence.
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Actitud Frente a la Salud , Conducta de Elección , Supervivencia sin Enfermedad , Prioridad del Paciente , Médicos , Calidad de Vida , Neoplasias del Recto/terapia , Adulto , Anciano , Quimioradioterapia , Colostomía , Incontinencia Fecal , Femenino , Gastroenterólogos , Humanos , Masculino , Persona de Mediana Edad , Oncólogos , Medición de Resultados Informados por el Paciente , Complicaciones Posoperatorias , Proctectomía , Disfunciones Sexuales Fisiológicas , Cirujanos , Encuestas y Cuestionarios , Incontinencia Urinaria , Espera VigilanteRESUMEN
PURPOSE: Many apparent differences exist in aetiology, genetics, anatomy and treatment response between colon cancer (CC) and rectal cancer (RC). This study examines the differences in patient characteristics, prevalence of complications and their effect on short-term survival, long-term survival and the rate of recurrence between RC and CC. METHODS: For all stage II-III CC and RC patients who underwent resection with curative intent (2006-2008) in five hospitals in the Netherlands, occurrence of complications, crude survival, relative survival and recurrence rates were compared. RESULTS: A total of 767 CC and 272 RC patients underwent resection. Significant differences were found for age, gender, emergency surgery, T-stage and grade. CC patients experienced fewer complications compared to RC (p = 0.019), but CC patients had worse short-term mortality rates (1.5 versus 6.7 % for 30-day mortality, p = 0.001 and 5.2 versus 9.5 % for 90-day mortality, p = 0.032). The adjusted HR (overall survival) for CC patients with complications was 1.57 (1.23-2.01; p < 0.001) as compared to patients without complications; for RC, the HR was 1.79 (1.12-2.87; p = 0.015). Relative survival analyses showed high excess mortality in the first months after surgery and a sustained, prolonged negative effect on both CC and RC. Complications were associated with a higher recurrence rate for both CC and RC; adjusted analyses showed a trend towards a significant association. CONCLUSION: Large differences exist in patient characteristics and clinical outcomes between CC and RC. CC patients have a significantly higher short-term mortality compared to RC patients due to a more severe effect of complications.
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Neoplasias del Colon/cirugía , Recurrencia Local de Neoplasia/patología , Complicaciones Posoperatorias/etiología , Neoplasias del Recto/cirugía , Anciano , Neoplasias del Colon/mortalidad , Femenino , Humanos , Masculino , Neoplasias del Recto/mortalidad , Tasa de Supervivencia , Factores de TiempoRESUMEN
BACKGROUND: Both preoperative short-course radiotherapy (SC-PRT) and preoperative long-course chemo radiotherapy (CRT) have shown to reduce local recurrence rates after total mesorectal excision (TME), but neither resulted in improved survival. This study compared the long-term health-related quality of life (HRQL) and symptoms between CRT and SC-PRT. METHODS: Patients who were preoperatively treated with a total dose of 50.0 to 50.4 Gy for locally advanced rectal cancers were identified from 2 hospital registries. Starting from 2011, all patients who were disease-free in the study population (n = 105) were sent a HRQL-questionnaire composed of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and questions on bowel and urinary function. Patients who underwent SC-PRT in the TME trial were used as a reference group. RESULTS: HRQL results from 85 patients receiving CRT (81.0%), with a median follow-up time of 58 months, were compared with the results of patients who underwent SC-PRT (n = 306). Apart from more nausea and vomiting reported by patients receiving CRT (mean score for CRT 5.9 vs. 1.3 for SC-PRT; P < .01; not clinically relevant) and less satisfaction with urinary function indicated by patients who received CRT (mean score for CRT 71.2 vs. 81.2 for SC-PRT; P < .01), no significant differences were found in HRQL and symptoms between patients who received CRT and SC-PRT. CONCLUSIONS: This analysis of HRQL in patients who received CRT shows no clinically relevant differences in long-term HRQL and symptoms between patients who received CRT and SC-PRT, apart from less satisfaction with urinary function reported by patients who received CRT. These results indicate that both approaches have a comparable impact on long-term HRQL.
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Adenocarcinoma/radioterapia , Radioterapia/efectos adversos , Radioterapia/métodos , Neoplasias del Recto/radioterapia , Adenocarcinoma/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Quimioradioterapia/efectos adversos , Quimioradioterapia/métodos , Procedimientos Quirúrgicos del Sistema Digestivo , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Terapia Neoadyuvante/efectos adversos , Terapia Neoadyuvante/métodos , Calidad de Vida , Neoplasias del Recto/tratamiento farmacológico , Estudios Retrospectivos , Encuestas y CuestionariosRESUMEN
BACKGROUND AND PURPOSE: Chemoradiotherapy (CRT) followed by surgery is the standard of care for locally advanced rectal cancer (LARC). For grade ⩾3 acute diarrhea there is a relationship between dose and irradiated small bowel volume. The aim of this study was to evaluate whether combined placement of a diverting stoma and sigmoid spacer (DSSS) led to reduced irradiated small bowel volume and less grade ⩾3 acute diarrhea in the treatment of LARC. MATERIALS/METHODS: Between 2003 and 2010, 54 of 189 LARC patients treated with CRT in two institutions had a DSSS prior to CRT. Data on patient and treatment characteristics and outcomes were collected retrospectively. Delineation of small bowel was performed with planning CT-scans. CTCAE version 4.0 was used for acute toxicity. RESULTS: Patients with a DSSS had significantly less small bowel volume irradiated up to doses of 20Gy. This difference was not observed for the higher dose levels. CRT induced grade ⩾3 acute diarrhea was not different between the two groups (8.3% vs. 12.8%; p=0.41). CONCLUSION: DSSS is not clearly beneficial to reduce grade ⩾3 acute diarrhea, and it must be considered whether placement of a DSSS is justified for this purpose.
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Quimioradioterapia/efectos adversos , Neoplasias del Recto/radioterapia , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Neoplasias del Recto/patología , Estudios Retrospectivos , Estomas Quirúrgicos , Tomografía Computarizada por Rayos XRESUMEN
A single dose of irradiation to the lumpectomy cavity alone after breast-conserving surgery in breast cancer patients has been available in the Netherlands since 2011. This new treatment modality is used in the Haaglanden Medical Centre in The Hague and in the Catharina Hospital in Eindhoven. The goal of intraoperative radiation therapy is to limit the patient burden caused by whole breast irradiation, while maintaining excellent local tumour control. The technique is used only in patients with a low probability of recurrent disease in the breast. Approximately 150 patients receive intraoperative radiation therapy each year In the Netherlands, an estimated 4,000 breast cancer patients were eligible in 2013 for this new treatment technique or another method of partial breast irradiation. In both hospitals the results are closely monitored. Only 15 of the first 200 patients experienced a side effect within a period of 3 months after intraoperative radiation therapy. These side effects were successfully treated either with antibiotics or with surgery.
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Braquiterapia/métodos , Neoplasias de la Mama/radioterapia , Neoplasias de la Mama/cirugía , Mastectomía Segmentaria , Adulto , Terapia Combinada , Femenino , Humanos , Cuidados Intraoperatorios , Persona de Mediana Edad , Recurrencia Local de Neoplasia/prevención & control , Países Bajos , Dosificación Radioterapéutica , Radioterapia Adyuvante , Resultado del TratamientoRESUMEN
BACKGROUND: From 2006 to 2008, an audit of the multidisciplinary diagnosis and treatment of colorectal cancer patients in the western part of the Netherlands was carried out. We evaluated whether compliance with guidelines had improved. METHODS: All patients with newly diagnosed and surgically treated colon (n = 1,667) and rectal cancer (n = 544) stage I-III were evaluated. Nine quality indicators were derived from the evidence-based guidelines. In order to compare hospital performances, hospital results were adjusted for casemix differences between hospitals. RESULTS: Colon cancer patients showed an increase in the examination of 10 or more lymph nodes (from 53% to 78%, P < 0.0001). For rectal cancer patients there was an increase in preoperative visualisation of the total colon (63-74%, P = 0.02), MRI (73-85%, P = 0.003), radiotherapy (from 82% to 93% for patients <75 years, P = 0.01) and examination of at least 10 lymph nodes (40-55%, P = 0.004). In 2006, standardised hospital performances differed widely for all quality indicators. Two years later, hospital performances for some quality indicators were more similar. CONCLUSIONS: After the feedback of benchmark information, compliance with guidelines for diagnosis and treatment of colorectal cancer patients improved, and differences between individual hospitals decreased. Although secular trends cannot be ruled out, it is highly likely that these results can be attributed to the audit.
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Neoplasias Colorrectales/diagnóstico , Neoplasias Colorrectales/terapia , Adhesión a Directriz/estadística & datos numéricos , Hospitales/normas , Auditoría Médica , Guías de Práctica Clínica como Asunto , Indicadores de Calidad de la Atención de Salud , Anciano , Benchmarking , Grupos Diagnósticos Relacionados , Femenino , Hospitales/estadística & datos numéricos , Humanos , Comunicación Interdisciplinaria , Modelos Logísticos , Metástasis Linfática/diagnóstico , Masculino , Persona de Mediana Edad , Análisis Multivariante , Estadificación de Neoplasias , Países Bajos , Oportunidad Relativa , Factores de TiempoRESUMEN
OBJECTIVE: To determine whether the quality indicator 'tumour positive surgical margin following breast-conserving surgery, consistently measured the quality of breast-cancer surgery independently of the different definitions used and differences in case mix, taking statistical random variation into account. DESIGN: Descriptive study. METHODS: Data was collected from 762 patients who underwent breast-conserving surgery for invasive or in situ carcinoma of the breast, in the period 1 July 2007 - 30 June 2008 in 1 of the 9 hospitals in the region of the Comprehensive Cancer Centre West in the Netherlands. We compared 3 definitions for 'tumour positive surgical margin': the one used by the Health Care Inspectorate, the one used by the organisation 'Zichtbare Zorg' ('transparent care') and the percentage of re-resection. For case mix correction we identified risk factors for tumour margin positivity with logistic regression. The results were presented in a funnel plot, using 95% confidence interval (CI) around the national standard of 20%. RESULTS: Depending on the definition used, the tumour positive surgical margin rate of the total group varied from 11 to 21%. Individual hospital rates varied by up to 19%. In situ carcinoma was associated with higher tumour positive surgical margin rates. Results differed significantly between hospitals for all 3 definitions. However, the funnel plot showed that results for most hospitals fell within the 95% CI of the standard. Whether a hospital fell within the 95% CI of the standard depended upon on the definition used and case mix correction. CONCLUSION: The lack of a single definition for the quality indicator 'tumour positive surgical margin following breast-conserving surgery' and the lack of case-mix correction undermine the validity of the indicator. Standardisation of definitions, uniform registration and the use of funnel plots can provide a more transparent insight into the quality of care.
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Neoplasias de la Mama/cirugía , Mama/patología , Carcinoma in Situ/cirugía , Mastectomía Segmentaria , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/patología , Carcinoma in Situ/patología , Quimioterapia Adyuvante , Femenino , Humanos , Modelos Logísticos , Persona de Mediana Edad , Recurrencia Local de Neoplasia , Estadificación de Neoplasias , Neoplasia Residual , Calidad de la Atención de Salud , Medición de Riesgo , Resultado del TratamientoRESUMEN
BACKGROUND: With the availability of infliximab, nowadays recurrent Crohn's disease, defined as disease refractory to immunomodulatory agents that has been treated with steroids, is generally treated with infliximab. Infliximab is an effective but expensive treatment and once started it is unclear when therapy can be discontinued. Surgical resection has been the golden standard in recurrent Crohn's disease. Laparoscopic ileocolic resection proved to be safe and is characterized by a quick symptom reduction. The objective of this study is to compare infliximab treatment with laparoscopic ileocolic resection in patients with recurrent Crohn's disease of the distal ileum with respect to quality of life and costs. METHODS/DESIGN: The study is designed as a multicenter randomized clinical trial including patients with Crohn's disease located in the terminal ileum that require infliximab treatment following recent consensus statements on inflammatory bowel disease treatment: moderate to severe disease activity in patients that fail to respond to steroid therapy or immunomodulatory therapy. Patients will be randomized to receive either infliximab or undergo a laparoscopic ileocolic resection. Primary outcomes are quality of life and costs. Secondary outcomes are hospital stay, early and late morbidity, sick leave and surgical recurrence. In order to detect an effect size of 0.5 on the Inflammatory Bowel Disease Questionnaire at a 5% two sided significance level with a power of 80%, a sample size of 65 patients per treatment group can be calculated. An economic evaluation will be performed by assessing the marginal direct medical, non-medical and time costs and the costs per Quality Adjusted Life Year (QALY) will be calculated. For both treatment strategies a cost-utility ratio will be calculated. Patients will be included from December 2007. DISCUSSION: The LIR!C-trial is a randomized multicenter trial that will provide evidence whether infliximab treatment or surgery is the best treatment for recurrent distal ileitis in Crohn's disease. TRIAL REGISTRATION: Nederlands Trial Register NTR1150.
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Antiinflamatorios/uso terapéutico , Anticuerpos Monoclonales/uso terapéutico , Colon/cirugía , Enfermedad de Crohn/terapia , Íleon/cirugía , Laparoscopía/economía , Antiinflamatorios/economía , Anticuerpos Monoclonales/economía , Enfermedad de Crohn/tratamiento farmacológico , Enfermedad de Crohn/cirugía , Humanos , Infliximab , Calidad de Vida , RecurrenciaRESUMEN
BACKGROUND: Isolated hepatic perfusion with high-dose chemotherapy is a treatment option for patients with irresectable metastases confined to the liver. Prolonged local control and impact on survival have been claimed. Major drawbacks are magnitude and costs of the procedure. We developed an isolated hypoxic hepatic perfusion (IHHP) with retrograde outflow without the need for a heart-lung machine. PATIENTS AND METHODS: Twenty-four consecutive patients with irresectable metastases of various origins were treated. IHHP inflow was via the hepatic artery, outflow via the portal vein with occlusion of the retrohepatic caval vein. Radiolabeled albumine was used for leakage monitoring. Melphalan was used at 1-2 mg/kg. A 25-minute perfusion period was followed by a complete washout. Local and systemic melphalan concentrations were determined. RESULTS: Compared with oxygenated classical IHP, the IHPP procedure reduced operation time from >8 h to 4 hours, blood loss from >4000 to 900 cc and saved material and personnel costs. Leakage was 0% with negligible systemic toxicity and 0% perioperative mortality. Tumor response: complete response (CR) in 4%, partial response (PR) in 58%, and stable disease (SD) in 13%. Median time to progression was 9 months (2-24 months); pharmacokinetics demonstrated intrahepatic melphalan concentrations more than 9 fold higher than postperfusion systemic concentrations. CONCLUSIONS: IHPP is a relatively simple procedure with reduced costs, reduced blood loss, no mortality, limited toxicity, and response rates comparable to classic IHP. The median duration of 9 months of tumor control should be improved. Hereto, vasoactive drugs, will be explored in further studies.
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Antineoplásicos Alquilantes/uso terapéutico , Quimioterapia del Cáncer por Perfusión Regional/métodos , Neoplasias Hepáticas/tratamiento farmacológico , Neoplasias Hepáticas/secundario , Melfalán/uso terapéutico , Adulto , Anciano , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Colorrectales/patología , Neoplasias Colorrectales/cirugía , Progresión de la Enfermedad , Neoplasias del Ojo/tratamiento farmacológico , Neoplasias del Ojo/patología , Neoplasias del Ojo/cirugía , Femenino , Estudios de Seguimiento , Cromatografía de Gases y Espectrometría de Masas , Arteria Hepática/efectos de los fármacos , Humanos , Infusiones Intraarteriales , Neoplasias Hepáticas/cirugía , Masculino , Persona de Mediana Edad , Neoplasias Primarias Desconocidas/tratamiento farmacológico , Neoplasias Primarias Desconocidas/patología , Neoplasias Primarias Desconocidas/cirugía , Vena Porta/efectos de los fármacos , Sarcoma/tratamiento farmacológico , Sarcoma/patología , Sarcoma/cirugía , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
PURPOSE: This study was designed to analyze the results of a multimodality treatment using preoperative radiotherapy, followed by surgery and intraoperative radiotherapy in patients with primary locally advanced rectal cancer. METHODS: Between 1987 and 2002, 123 patients with initial unresectable and locally advanced rectal cancer were identified in our prospective database, containing patient characteristics, radiotherapy plans, operation notes, histopathologic reports, and follow-up details. An evaluation of prognostic factors for local recurrence, distant metastases, and overall survival was performed. RESULTS: All patients were treated preoperatively with a median dose of 50 Gy radiotherapy. Surgery was performed six to ten weeks after radiotherapy. Twenty-seven patients were treated with intraoperative radiotherapy because margins were incomplete or =2 mm. Postoperative mortality was 2 percent. The median follow-up of all patients was 25.1 months. The overall five-year local control was 65 percent and the overall five-year survival was 50 percent. Positive lymph nodes and incomplete resections negatively influenced local control and overall survival. Intraoperative radiotherapy improved five-year local control (58 vs. 0 percent, P = 0.016) and overall survival (38 vs. 0 percent, P = 0.026) for patients with R1/2 resections. CONCLUSIONS: The presented multimodality treatment is feasible with an acceptable mortality and a five-year overall survival of 50 percent. Addition of intraoperative radiotherapy for patients with a narrow or microscopic incomplete resection seems to overrule the unfavorable prognostic histologic finding.
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Adenocarcinoma/radioterapia , Adenocarcinoma/cirugía , Neoplasias del Recto/radioterapia , Neoplasias del Recto/cirugía , Adenocarcinoma/mortalidad , Adenocarcinoma/secundario , Adulto , Anciano , Anciano de 80 o más Años , Terapia Combinada , Femenino , Humanos , Periodo Intraoperatorio , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia , Complicaciones Posoperatorias , Neoplasias del Recto/mortalidad , Neoplasias del Recto/patología , Tasa de SupervivenciaRESUMEN
PURPOSE: When local recurrent rectal cancer is diagnosed without signs of metastases, a potentially curative resection can be performed. This study was designed to compare the results of preoperative radiotherapy followed by surgery with surgery only. METHODS: Between 1985 and 2003, 117 patients with recurrent rectal cancer were prospectively entered in our database. Ninety-two patients were suitable for resection with curative intent. Preoperative radiation with a median dosage of 50 Gy was performed in 59 patients; 33 patients did not receive preoperative radiotherapy. The median age of the patients was respectively 66 and 62 years. RESULTS: The median follow-up of patients alive for the total group was 16 (range, 4-156) months. Tumor characteristics were comparable between the two groups. Complete resections were performed in 64 percent of the patients who received preoperative radiation and 45 percent of the nonirradiated patients. A complete response after radiotherapy was found in 10 percent of the preoperative irradiated patients (n = 6). There were no differences in morbidity and reintervention rate between the two groups. Local control after preoperative radiotherapy was statistically significantly higher after three and five years (P = 0.036). Overall survival and metastases-free survival were not different in both groups. Complete response to preoperative radiotherapy was predictive for an improved survival. CONCLUSIONS: Preoperative radiotherapy for recurrent rectal cancer results in a higher number of complete resections and an improved local control compared with patients treated without radiotherapy. Preoperative radiotherapy should be standard treatment for patients with recurrent rectal cancer.
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Recurrencia Local de Neoplasia/radioterapia , Recurrencia Local de Neoplasia/cirugía , Neoplasias del Recto/radioterapia , Neoplasias del Recto/cirugía , Anciano , Terapia Combinada , Femenino , Humanos , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia/patología , Cuidados Preoperatorios , Pronóstico , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Dosificación Radioterapéutica , Radioterapia Adyuvante , Neoplasias del Recto/patología , Análisis de Supervivencia , Resultado del TratamientoRESUMEN
BACKGROUND: Isolated hepatic perfusion for irresectable metastases confined to the liver has reported response rates of 50% to 75%. Magnitude, costs, and nonrepeatability of the procedure are its major drawbacks. We developed a less invasive, less costly, and potentially repeatable balloon catheter-mediated isolated hypoxic hepatic perfusion (IHHP) technique. METHODS: In this phase I and II study, 18 consecutive patients with irresectable colorectal or ocular melanoma hepatic metastases were included. Two different perfusion methods were used, both with inflow via the hepatic artery, using melphalan 1 mg/kg. In the first eight patients, the portal vein was occluded, and outflow was via the hepatic veins into an intracaval double-balloon catheter. This orthograde IHHP had on average 56% leakage. In next 10 patients, we performed a retrograde outflow IHHP with a triple balloon blocking outflow into the caval vein and allowing outflow via the portal vein. The retrograde IHHP still had 35% leakage on average. RESULTS: Although local drug concentrations were high with retrograde IHHP, systemic toxicity was still moderate to severe. Partial responses were seen in 12% and stable disease in 81% of patients. The median time to local progression was 4.8 months. CONCLUSIONS: We have abandoned occlusion balloon methodology for IHHP because it failed to obtain leakage control. We are presently conducting a study using a simplified surgical retrograde IHHP method, in which leakage is fully controlled, which translates into high response rates.